Gait Adaptability in Persons With MS Having Mild Disability
Multidimensional Assessment of Gait Adaptability in Persons Multiple Sclerosis With no to Mild Disability
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that frequently leads to walking impairment, balance deficits, fatigue, cognitive difficulties, and an increased risk of falls. Importantly, these problems can already be present in the early stages of the disease and may not be adequately captured by standard clinical walking tests, which primarily assess speed or distance. Such tests are often insufficient to reflect the complexity of real-life walking, which requires continuous adaptation to environmental challenges, and attention to internal and external stimuli.
Gait adaptability, the ability to modify walking patterns in response to changing and unpredictable demands such as obstacles or sudden perturbations, is critical for safe mobility and fall prevention. Both proactive (anticipatory) and reactive (feedback-driven) gait adaptations are essential for maintaining balance and functional independence. However, gait adaptability and its underlying neural mechanisms remain insufficiently understood in people with MS.
This study aims to provide a comprehensive assessment of gait adaptability in people with MS by evaluating both proactive and reactive gait adaptations using objective gait measurements and cortical activity recordings. The findings may contribute to the development of more sensitive outcome measures and inform targeted rehabilitation strategies that better reflect real-life mobility demands.
Primary aims:
• To investigate the behavioral measures and neural correlates of reactive and proactive gait adaptability in pwMS compared to HC
Secondary aims:
- To investigate factors related to gait adaptability
- To investigate changes in gait adaptability during prolonged walking conditions
Descripción general del estudio
Estado
Condiciones
Descripción detallada
A total of 16 persons with MS will be recruited. In addition, 16 healthy controls, matched for age and sex, will be recruited for comparison. Participants will be recruited by researchers from the REVAL Research Center at Hasselt University using the REVAL website and social media platforms, as well as those of relevant organizations. Healthy control participants will be recruited via flyers and social media, with age- and sex-matching applied using a 5-year age range.
The study consists of a single testing session. Outcomes will be recorded using time- and observation-based methods, and movement sensors will be used for motor performance tests, including the Timed 25-Foot Walk Test, Foot Tap Test, Heel Rise Test, 2-Minute Stepping Test, Six-Spot Step Test, and the 6-Minute Walk Test. Self-report questionnaires, including the Falls Efficacy Scale-International, Multiple Sclerosis Walking Scale, Modified Fatigue Impact Scale, Activities-specific Balance Confidence Scale, Gait-Specific Attention Profile, and Balance Recovery Confidence Scale, will be administered. The Mini-BESTest and cognitive tests, including SDMT and BVMT-R will be performed to assess balance and cognitive functions.
Proactive gait adaptability will be assessed using an overground gait adaptability test (i.e., the Walking Adaptability Ladder Test). Participants will walk along a 10-meter walkway with stepping targets indicated by bars and rows that progressively decrease in size. They will be instructed to adapt their steps to the targets while walking at a fast pace. Three conditions will be performed, each lasting 20 seconds and repeated five times, with 15 seconds of rest between trials during which participants will stand upright. The conditions include walking with one step per target, walking with two steps per target, and a control walking condition consisting of usual walking over the 10-meter walkway at the fastest safe walking speed without running. Reactive gait adaptability will be evaluated using an instrumented augmented reality system (Computer Assisted Rehabilitation Environment Extended [CAREN]; Motekforce Link, The Netherlands). Twelve unannounced repetitive perturbations will be applied. The CAREN system is designed for biomechanical analysis of human movement and utilizes high-resolution recordings via a 3D motion capture system equipped with 18 Vicon cameras (Vicon Motion Systems, Oxford, UK). The dual-belt treadmill incorporates two embedded force plates and allows for self-paced speed adjustments. Clinically relevant spatiotemporal gait parameters and gait stability measures will be processed. Cortical brain hemodynamics will be assessed using functional near-infrared spectroscopy (fNIRS; NIRSport™, NIRx, Germany), composed of 16 sources and 16 detectors. The fNIRS cap will be worn during both proactive and reactive gait adaptability conditions.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zuhal Abasiyanik, PhD
- Número de teléfono: +32(0)11 26 93 06
- Correo electrónico: zuhal.abasiyanik@uhasselt.be
Copia de seguridad de contactos de estudio
- Nombre: Peter Feys, PhD
- Número de teléfono: +32(0)11 26 21 23
- Correo electrónico: peter.feys@uhasselt.be
Ubicaciones de estudio
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Diepenbeek, Bélgica, 3500
- Reclutamiento
- REVAL Rehabilitation Research Center, University of Hasselt
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Contacto:
- Peter Feys
- Número de teléfono: +32 11 29 21 23
- Correo electrónico: peter.feys@uhasselt.be
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age between 18-65 years,
- confirmed diagnosis of definite MS,
- relapse free at least 30 days,
- Expanded Disability Status Scale (EDSS) score between 0 and 3.5
Exclusion Criteria:
- Diagnosed with neurological disease other than MS
- cognitive decline that renders the patient incapable of performing tests and questionnaires.
- Other neurological, orthopedic, or visual impairments affecting gait
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Multiple sclerosis
People presenting with multiple sclerosis diagnosis according to the 2017 revisions of the Mcdonald's criteria.
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Healthy controls
Inclusion criteria for healthy controls: inclusion of age between 18 and 65 years old, sex- and age-matched on a group level.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Walking Adaptability Ladder Test (WALT)
Periodo de tiempo: Day 1
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WALT is a measure of walking adaptability.
It has stepping targets that successively decrease in size, which forces a person to continually adapt step length and cadence to the targets.
All trials will be video recorded for the calculation of completion time (in seconds) and stepping errors and additionally recorded using inertial movement sensors.
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Day 1
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Reactive gait adaptations
Periodo de tiempo: Day 1
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Instrumented reactive gait adaptability will be evaluated using the safe augmented reality system (The Computer Assisted Rehabilitation Environment Extended- CAREN; Motekforce Link, NL). 12 unannounced repetitive perturbations will be applied.
Margin of stability, center of mass velocity and range, step width, step length, and knee kinematics will be recorded by the Vicon Motion System (VICON, Oxford, UK).
Adaptation across perturbations will be assessed by examining changes in these parameters over successive trials.
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Day 1
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Relative concentration of oxyhemoglobin and deoxyhemoglobin
Periodo de tiempo: Day 1
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The cortical brain hemodynamics during walking will be assessed through fNIRS (NIRSport TM, NIRX, Germany) composed of 16 sources and 16 detectors (wavelengths 760- 850nm).
The hemodynamic signals will be recorded at a sampling rate of 10.25 Hz.
A standard cap will be placed over each participant's scalp, and sources and detectors will be positioned on the measuring cap according to the 10-20 International system.
The spatial distribution of the optodes on the cap will be chosen to create channels (i.e., source-detector pairs) with standard inter-optode distances of a maximum 3 cm.
Optodes will be placed over both hemispheres to collect hemodynamic activity in bilateral PFC (Broadman areas 9,46 and 11), PMC (Broadman area 6), SMA (Broadman area 6), and Posterior parietal cortex (PPC-BA5,7).
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Day 1
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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La Escala de Marcha en la Esclerosis Múltiple (MSWS)
Periodo de tiempo: Día 1
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La Escala de Caminata Múltiple para la Esclerosis Múltiple (MSWS) incluye 12 ítems y evalúa las dificultades percibidas al caminar en la vida diaria.
Las puntuaciones más altas indican un mayor deterioro de la marcha relacionado con la EM.
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Día 1
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Fall history
Periodo de tiempo: Day 1
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The number of falls in the last 6 months will be questioned to compare the difficulties with (perceived) dual tasking between fallers and non-fallers.
A fall will be described as "an event where the participant unintentionally landed on the ground or a lower level."
Two questions will be asked to determine fall status and falls numbers: "Have you ever fallen in the last six months?"
If the response is yes, "How many times have you fallen?" will be asked.
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Day 1
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The Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: Day 1
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MFIS is a self-reported questionnaire that evaluates the effects of physical (9-items), psychosocial (2-items), and cognitive (10-items) dimensions of fatigue.
Higher scores show a higher perceived level of fatigue.
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Day 1
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Symbol Digit Modalities Test (SDMT)
Periodo de tiempo: Day 1
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Oral version of the SDMT will be used to evaluate cognitive processing speed.
The participants will be asked to match as many numbers and symbols as possible within 90 s.
The number of correct matches will be recorded.
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Day 1
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Brief Visuospatial Memory Test-Revised (BVMT-R)
Periodo de tiempo: Day 1
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BVMT-R will be used to assess short term visuospatial memory.
The participant has 3 attempts, viewing the same figures 3 times.
Each attempt can have a maximum score of 12 and the scores are summed together in a total score (0-36).
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Day 1
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Gait-Specific Attention Profile (GSAP)
Periodo de tiempo: Day 1
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GSAP includes four psychological constructs (anxiety, conscious movement processing, fall-related ruminations, processing efficiency) implicated in influencing the control of balance and gait.
It includes 11 items; items are rated 1 (not at all) to 5 (very much so).
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Day 1
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Balance Recovery Scale (BRC)
Periodo de tiempo: Day 1
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BRC evaluates compensatory stepping responses and balance recovery strategies following perturbations.
It includes a series of externally induced balance challenges in multiple directions.
The scale helps to identify impaired reactive balance control.
The total score ranges from 0 to 190.
A higher score shows a higher certainty of arresting a fall.
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Day 1
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MiniBest Test
Periodo de tiempo: Day 1
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The Mini-BESTest assesses dynamic balance across four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, and gait.
It consists of 14 tasks scored on a 3-point scale (0-2), yielding a total score ranging from 0 to 28, with higher scores indicating better balance performance.
The test has been validated in various populations, including individuals with neurological disorders.
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Day 1
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2-Minute Stepping Test (2MST)
Periodo de tiempo: Day 1
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2MST measures aerobic endurance and lower limb function and serves as a practical and space-efficient alternative to walking tests.
Participants step in place for two minutes, raising their knees to a target height, and the number of full steps is recorded, frequency and amplitude will be recorded by inertial movement sensors.
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Day 1
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Foot tap test (FTP)
Periodo de tiempo: Day 1
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Distal motor coordination and speed will be assessed by rapid foot taps performed at the maximal comfortable speed and amplitude for 10 seconds and 1 minute per foot.
Tap frequency and amplitude will be derived from the movement sensor data.
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Day 1
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The Six-Spot Step Test (SSST)
Periodo de tiempo: Day 1
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SSST will be used to evaluate dynamic balance and coordinated lower limb function.
Participants will be asked to step as quickly as possible over six evenly spaced foam blocks arranged on the floor, following a standardized sequence.
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Day 1
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The 6-Minute Walk Test (6MWT)
Periodo de tiempo: Day 1
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6MWT will be used to assess walking endurance.
Participants will be instructed to walk back and forth along a 30m, flat corridor for six minutes, covering as much distance as possible.
Spatiotemporal parameters (speed, cadence, step length, step duration, double support), variability, and asymmetry metrics will be evaluated by inertial movement sensors.
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Day 1
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The Heel Rise Test (HRT)
Periodo de tiempo: Day 1
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HRT evaluates the strength and endurance of the calf muscles.
Participants perform repeated single-leg heel raises (at least 5 cm) until fatigue or failure.
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Day 1
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The Timed-25 Foot Walk (T25FW)
Periodo de tiempo: Day 1
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T25FW will be applied to evaluate the fastest walking speed.
The test will be carried out on a flat pathway, 7.62 m long.
The participants will be instructed to walk as quickly and safely as possible.
The average score of the two trials will be reported.
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Day 1
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Activities Specific Balance Confidence Scale (ABC)
Periodo de tiempo: Day 1
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ABC is used to assess participants' self-perceived confidence in maintaining balance while performing various daily activities.
It includes 16 items; each rated from 0% (no confidence) to 100% (completely confident).
The average score is calculated, with higher scores reflecting greater balance confidence.
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Day 1
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Concern about falling
Periodo de tiempo: Day 1
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The Falls Efficacy Scale International (FES-I) will be used to evaluate concerns about falling.
The questionnaire consists of 16 items, each scored on a 4-point scale (1-4), resulting in a total score ranging from 16 to 64.
Higher scores indicate greater concern about falling.
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Day 1
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Primero enviado que cumplió con los criterios de control de calidad
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Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CME2024/032
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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